Catalog Number

120S

Brand Name

Ameritus

Version/Model Number

120S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

57f5cce9-7925-44ff-a84b-18f2f71048ce

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2016

Package DI Number

30817522010162

Quantity per Package

4880

Contains DI Package

10817522010168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case